None listed
Conditions
Brief summary
We are planning a Pilot study to look at the effectiveness of ingesting a multistrain probiotics for eight weeks in the treatment of Major Depressive Disorder in community along with conventional biological treatment, antidepressants.Apart from the above, study also tries to clarify whether there will be a change in the levels of inflammatory markers called interleukin 1 and 6 due to the above intervention and does people's eating and lifestyle have any confounding effect in the above relationship.
Interventions
1.multistrain probiotics called Ecologic Barrier will be given.
strains used are Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58
2. Dose adminstered will be 5Billion CFU once daily
3.Powder reconstituted in water
4. Adherence is monitored through study specific questionnaire and face to face meetings.
5. They will continue on
1.multistrain probiotics called Ecologic Barrier will be given. strains used are Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 2. Dose adminstered will be 5Billion CFU once daily 3.Powder reconstituted in water 4. Adherence is monitored through study specific questionnaire and face to face meetings. 5. They will continue on their standard antidepressant therapy prescribed by their treating clinician and taken as per clinician advice.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
-Adults aged between 18 and 65 years - Living in the community -English speaking -Able to give informed consent -Currently experiencing an episode of MDD of mild to moderate* severity based on the Diagnostic and statistical manual of mental disorders (5th ed.) - Attending an existing health care provider * Mild: Few,If any, symptoms in excess of those required to make the diagnosis are present,the intensity of the symptoms is distressing but manageable,an the symptoms result in minor impairment in social or occupational functioning. Moderate: The number of symptoms,intensity of symptoms,and/or functional impairment are between those specified for ‘mild’ and “severe”. Severe: The number of symptoms is substantially in excess of that required to make the diagnosis,the intensity of the symptoms is seriously distressing and unmanageable,and the symptoms markedly interfere with social and occupational functioning.
Exclusion criteria
- Illnesses that contribute to immunosuppression or inflammatory conditions -People who take immunosuppressants -Currently suffering from an infection and have been taking antibiotics -On regular medications other than antidepressants especially those which affect the gut microbiota (e.g., Omeprazole, over the counter probiotics) or anti-inflammatory medications like NSAID’s. -Acutely suicidal or at high risk of harming others or properties -Currently diagnosed with Schizophrenia, Schizoaffective disorder or eating disorder - Have been diagnosed with Bipolar Affective disorder in the past - Any form of substance abuse or dependence in the last two years. -Significant comorbid physical illnesses, e.g., autoimmune disorders, inflammatory bowel conditions, traumatic brain injury, neurological disorders
Outcome results
None listed